Identity
- Trade Name
- Silicone Block FDA UDI
- Generic Name
- Silicone-block tissue reconstructive material FDA UDI
- Device Name
- Silicone Block FDA UDI
- Model / Reference
- Size: 26.6mm x 23.4mm x 4.4mm FDA UDI
- Description
- Silicone Block FDA UDI
Identifiers
- Catalog Number
- BLK-BSC-1 FDA UDI
- Primary DI / UDI-DI
- M724BLKBSC11 FDA UDI
- 510(k) Number
- K913882 FDA UDI
- FDA Product Code
- MIB FDA UDI
- GMDN Term
- Silicone-block tissue reconstructive material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Silicone-block tissue reconstructive material
Silicone Block by Implantech Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K913882 also covers:
- Rectangular Carving Block 2.0 — Implantech Associates, Inc.
- Rectangular Carving Block 2.0 — Implantech Associates, Inc.
- Rectangular Carving Block 2.0 — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
- Silicone Block — Implantech Associates, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Implantech Associates, Inc.
Sources (1)
- FDA UDI 520149bf-d548-4bdc-85aa-fd888c167bc7 36 fields · synced Jun 9, 2026